Patient-prosthesis mismatch in new generation trans-catheter heart valves: a propensity score analysis

Théron, Alexis; Pinto, Johan; Grisoli, Dominique; Griffiths, Karolina; Salaün, Erwan; Jaussaud, Nicolas; Ravis, Eléonore; Lambert, Marc; Messous, Lyna; Amanatiou, Cecile; Cuisset, Thomas; Gariboldi, Vlad; Giorgi, Roch; Habib, Gilbert; Collart, Frédéric

doi:10.1093/ehjci/jex019

Cited by 26 publications

(20 citation statements)

References 24 publications

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“… 12) One small prospective study in France showed that the S3 group had small EOA and EOAI, and that there was more frequent prosthesis-patient mismatch rate in the S3 group compared to that with SXT. 26) Prosthesis-patient mismatch was most frequent in the 23-mm-sized S3 THV in the study.…”

Section: Discussionmentioning

confidence: 68%

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients

et al. 2020

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Background and Objectives The Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices. Methods A total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days. Results The Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs. 0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm 2 ; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001–0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, all-cause mortality, and disabling stroke at 1 year were similar between the 2 groups. Conclusions Cardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.

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Section: Discussionmentioning

confidence: 68%

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients

et al. 2020

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“…Compared to the CoreValve, Evolut R yielded a similar EOA (1.90 ± 0.64 vs. 1.88 ± 0.59 cm 2 , P = 0.19) but a slightly higher mean PG (7.9 ± 4.6 vs. 8.6 ± 5.5 mmHg, P < 0.001) in one large registry . Compared to Sapien XT, the next generation Sapien 3 showed a significantly higher transvalvular PG and PPM rate in one study . The authors suggested that the outer annular sealing polyethylene terephthalate skirt, which functions as a blood‐soaked sponge, bulges into the annular space impeding free forward blood flow.…”

Section: Discussionmentioning

confidence: 95%

“…21 Compared to Sapien XT, the next generation Sapien 3 showed a significantly higher transvalvular PG and PPM rate in one study. 22 The authors suggested that the outer annular sealing polyethylene terephthalate skirt, which functions as a blood-soaked sponge, bulges into the annular space impeding free forward blood flow. Our findings, however, suggest that reduced oversizing of Sapien 3 is more to blame for the observed smaller EOA and the higher PPM rate than a specific design feature.…”

Section: The Incidence and Predictors Of Ppm After Tavrmentioning

confidence: 99%

Impact of prosthesis‐iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement

Abdelghani

Allali

Kaur

et al. 2018

Cathet Cardio Intervent

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Objectives To investigate the impact of the introduction of the next generation self‐expanding (SE) and balloon‐expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). Background PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. Methods PPM was assessed at 30 days post‐TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). Results The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95–0.99], P = 0.002), history of myocardial infarction (2.09 [1.00–4.34], P = 0.049), annulus maximum diameter (0.84 [0.77–0.92], P < 0.001), and THV oversizing (0.90 [0.87–0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23–8.53], P = 0.017 and 5.79[2.33–14.36], P < 0.001). Conclusions The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

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“…Higher incidence of PPM in the newer Sapien 3 valves has been previously reported . Possible causes of higher PPM risk with Sapien S3 valve include less oversizing compared to Sapien XT and the added outer skirt that may contribute to narrowing of the effective orifice area, relative impedance on the systolic blood flow, and therefore, higher risk of PPM, compared with self‐expandable valves. Evolut PRO/R valves employ a supra‐annular implantation approach rather than intra‐annular as in Edwards Sapien valves, which may lead to better postoperative hemodynamics …”

Section: Discussionmentioning

confidence: 77%

Predictors and outcomes of patient‐prosthesis mismatch after transcatheter aortic valve replacement

et al. 2019

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Background: Patient-prosthesis mismatch (PPM) has been shown to be associated with adverse outcomes after surgical aortic valve replacement. There is limited data on its risk and impact after transcatheter aortic valve replacement (TAVR), especially with the newer generation heart valves.Objectives: The objective of this study is to investigate the incidence, predictors, and clinical outcomes of PPM after TAVR.Methods: This is a retrospective study of 991 consecutive patients who underwent TAVR procedure at a tertiary referral center, between April 2012 and February 2019. Patients were stratified by the presence or absence of PPM, defined as an effective orifice area/body surface area ratio ≤0.85 cm 2 /m 2 . Multivariable logistic regression analysis was used to determine independent predictors of PPM. Kaplan-Meier survival estimates were used to determine overall 5-year survival.Results: PPM was encountered in 27.6% of patients. In multivariable analysis, age less than 70 years (P = .062), body mass index (BMI) more than 30 (P = .0057), history of atrial fibrillation (P = .0004), black race (P = .0078), and Sapien 3 sizes 20 and 23 mm (P < .0001)emerged as independent predictors of PPM. Sapien 3 valve size 20/23 mm was associated with higher risk of PPM compared to other valve types. Patients with PPM had comparable postoperative outcomes and overall 5-year survival. There was no significant difference in postoperative complications between patient groups. PPM was not associated with worse overall survival (56% for both PPM and no-PPM patients, log-rank P = .80).Conclusions: Younger age, atrial fibrillation, black race, higher BMI were predictors of PPM. Smaller sizes balloon-expandable valves had a higher risk of PPM. K E Y W O R D S aortic stenosis, cardiac surgery, patient-prosthesis mismatch, TAVR Abbreviations: TAVR, transcatheter aortic valve replacement; SAVR, surgical aortic valve replacement; PPM, patient-prosthesis mismatch; BMI, body mass index.

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Patient-prosthesis mismatch in new generation trans-catheter heart valves: a propensity score analysis

Cited by 26 publications

References 24 publications

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients

Impact of prosthesis‐iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement

Predictors and outcomes of patient‐prosthesis mismatch after transcatheter aortic valve replacement

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